Hand Sanitizer Antiseptic Gel

Hand Sanitizer Antiseptic by

Drug Labeling and Warnings

Hand Sanitizer Antiseptic by is a Otc medication manufactured, distributed, or labeled by ComStar International Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZER ANTISEPTIC- isopropyl alcohol gel 
ComStar International Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Hand Sanitizer Antiseptic Gel

Drug Facts

Active ingredients

Isopropyl alcohol 75% v/v

Purpose

Antiseptic

Use(s)

  • Hand sanitizer to help reduce bacteria that potentially can cause disease.
  • For use when soap and water are not available.

Warnings

For external use only.

Flammable. Keep away from fire or flame.

Do not use

  • in children less than 2 months of age
  • on open skin wounds
  • in the eyes

Stop use and ask a doctor

  • if irritation and redness develop.
  • conditions persists for more than 72 hours.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Contrl Center right away.

Directions

Wet hands thoroughly with product and allow to dry without wiping.

Other Information

Store between 59-86° F (15-30°C). Avoid extreme temperatures (below 0°F and above 140°F).

Inactive ingredients

Glycerin. hydrogen peroxide, purified water, polyethylene glycol, acrylate polymer

Package Labeling:

Bottle

HAND SANITIZER ANTISEPTIC 
isopropyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 74925-275
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.75 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
WATER (UNII: 059QF0KO0R)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 74925-275-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product07/05/202003/31/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E07/05/202003/31/2022
Labeler - ComStar International Inc. (612836601)

Revised: 9/2022
Document Id: e96413d6-2839-38dd-e053-2995a90a43e1
Set id: abfd7c66-c628-cf58-e053-2a95a90a9276
Version: 2
Effective Time: 20220923